Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture
FDA device recall Z-0233-2016 · posted 2015-11-06 · Terminated
Recall details
- Recalling firm
- Utah Medical Products, Inc
- Reason for recall
- Utah Medical is conducting a recall of Myelo-Nate CSF Sampling Kit due to an internal post-sterilization inspection that found a sterile finished tray where the seal between the Tyvek lid and the PETG tray on one side of the tray had been compromised.
- Action taken
- Consignees notified on 10/15/15 via letter and email, instructed to return product to distributor.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- KDD
- Quantity affected
- 21,403 trays
- Distribution
- Worldwide Distribution-US (nationwide) including Puerto Rico and the states of CA, CO, MD, WI, FL, GA, IL, IA, ID, IN, KS, KY, LA, MI, MN, MO, MS, NC, NE, NJ, NV, OH, OK, OR, PA, SC, TN, TX, VA, WA, a
- Date initiated
- 2015-10-16
- Date posted
- 2015-11-06
- Date terminated
- 2016-05-02
- Location
- Midvale, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMO-NATE L-P KIT (K821814) | Int'L Corp. | 1982-07-09 |